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Contents
1. Annex ll 3 Annex V Annex VI Product Certificate Soh AE Ot SIED TEDIS Fo 7 aN MCCS PAn Annex II 4 Annex Ill Annex IV Minimum documentation that must be submitted FEW TEE RIE OBS BAIXKIVT SiBMHWABRMLSH CHEEK CEBRS SOET Application plus Appendix B RERU Appendix B Excerpt from the register of companies Transition plan for product labeling SHS RAR OORT N mDNER ADM THE Application plus Appendix B HERU Appendix B Audit report or site certificate BSEARABELILU HAMAS OEE Application plus Appendix A RERU Appendix A Audit report product category Design dossier product or design verification Variant FERES mATIV TRIE VIN MERLE SUZY R Application plus Appendix B where appropriate Appendix C HERU Appendix B WEITE LT Appendix C Audit report or site certificate SAREE KLASSE Application Depending on the change e g validation reports REABI ko THRUST zE Pl R HEARES Application plus Appendix C ASRU Appendix C EC certificate and contract with OEM supplier Action list for supplier control OEM HEO EC BMitBSRURHE HEE SHEORODPIVAYVUAR Type of change ERAS Change in critical Process BEGTOCZAILES SER Change of authorized representative HERBAORS Change in the application as intended and or indication BAMLEMILRRLEBAO Eas Change in product Specification Ri mnt SA Change in product indication Ri mRnOR A Additional acces2. 20 BE ace EEL D c List of submitted documents Additional information in Appendix F cre Ae ACL TIES RAMEE RS SMAI Fry 7AM Appendix F ECAR le HEM amp SCHL KC Ha TUV SUD Product Service GmbH Tw File MED_F_09 04 pdf Revision 38 Effective 2012 07 16 Page 3ofs Type of change EAA New owner new name new address STRATA a Pie Ph HE PT Site related changes H41 SRA IAT oR Additional product Category Product Variant ATI Y R NPL RAFINI Transfer of processes to other sites FALADILDOYIE ADB ir Change in production Technology HEROS Change of suppliers fii O po Changes related to Example fl Change of certificate holder ROA St AA a 2 Be Relocation or new site Closure of site HOE OME RITIED Product category applicable to QMS Product Variant applicable to product TAMSILLAR hA 8 RATIAY Sia ASH SM MIL Pb Transfer of development or Production processes to another site REH Rie TALADIMOY ADE Outsourcing of a production process to a critical supplier HETOALADERSRRANOST IE A Changes in production technology or application to another product family Bei OE PEON MFO Change in special production Process e g new sterilization method changes in sterilization method PRS ERO ES Hl AL Ma KK RADACH SES OEM suppliers Critical suppliers OEM tea ERORA QMS Certificate mavAT Ls UF ORE 2 BOCH TEORA FIJJTA n TLES Dy IS013485
3. CRA MILES ISRAEBRUUELET OBSiAA AF RES PDF CF amp I4z LE l2oO Appendix D amp c HMW lt ESLY AppendixD RATIA PRTA NRH SEEGRRONE Plans for substantial change s to the quality management system product a BHAEAACIESL HM Chiat CT Manufacturer Vora IDF VI TSJ aggro Pips Ss ID No amp f lt fESLY ll Bs PUUT LBS AGE B R Appendix CEE TACA AEA HAIEK 3 Change notice BEBOMAAOWREA ACL Product Service Company name Street Number Suite Sumitomo Fudosan Nishi Shinjuku Bldg No 4 8F 4 33 4 Nishi Shinjuku Postal Code City Shinjuku ku 160 0023 Province State Country Tokyo Japan Contact Mr xxx Hise 1 lt Y Tel 81 3 3372 4261 SKEA Email ZA FAL mall xxxx tuv sud jp QexaORENAICFIYIEAN TES RRON CILSSAREBRL CHYVES Ng Changes relatedto S A Minimum documentation Type of change Certificate Certificate that must be submitted Application plus Appendix B New owner new name new address Site related changes Relocation or new site Change of certificate holder Excerpt from the register of companies Transition plan for product labelling Application plus Appendix B Closure of site Audit report or site certificate Product category Application plus Appendix A Additional product applicable to QMS Audit report product category category product variant Product variant Design dossier product or applicable to product desig
4. ge in safety related functions parformance data matarials parameters listed on the certificate identification instructions for use Name of product model Changes in the components in a system or set Minimum documentation that must be submitted Application Procedure process description Application plus Appendices B or C Excerpt from the register of companies contract with new EC representative transition plan for product labelling Application plus Appendix A Verification report clinical data Apolication Verification report Application plus Appendix 4 Verification report Application plus Appendix Alin case of a change in the product name or identification Verification report The required verification repart dependa on the type of change and may include for example risk management file Essential Raquirements checklist test reports ete Appendix D Plans for substantial change s to the quality management system product Manufacturer Product Service ERMCEOA EB SIZ A FAMAAET OBSAlL FLYVEAN Appendix F ECA ALHS a Description of the plans for changes old new comparison Additional information in Appendix F is 2 FRRAOHM IAOMREMLUWRELBLCCRACHEALY TERARIJ EL i Scope Change BIRMADA E 2208 A COsea SCE XXXXXX FEADAR OOC b Reason for change Additional information in Appendix FH b H CAMA EST SBRIL FIYVEAN Appendix F ECAIFACTESLY
5. n verification variant Transter of development or Application plus Appendix B Transfer of processes production processes to another site where appropriate Appendix C to other sites Outsourcing of a production process to a critical supplier Changes in production technology or application to another product family Change in production Audit report or site certificate Application technology Changes in special production Depending on the change e g validation reports processes e g new sterilization method changes in sterilization method Application plus Appendix C OEM suppliers Changes of suppliers EC certificate and contract with OEM supplier Critical suppliers TUV SUD Product Service GmbH Action list for supplier control Appendix D Plans for substantial change s to the quality management system product Manufacturer Application identification 2012 001 Type of change Changes in critical processes Change of authorized representative Change in the application as intended and or indication Change in product specifications Change in product identification Additional accessories Other please describe the change Changes in critical processes such development and vigilance system Change or relocation of authorized rapresentatve Change of the user and or use Additional amended indications Changels influencing the clinical performance data Chan
6. ppendix A In case of a change In the product name or identification Verification report AE RU Appendix A A mA EILA miRNA R WEFEIRDRA RIRES The required verification report depends on the type of change and may include for example risk management file Essential Requirements checklist test report etc Bia SONRISESOBRI LOCREY HAIL JRI ZRSAYKTIPI I BABA FIYIVAL RRR FCRECCEMHVET
7. sories HETH Other please describe the change TONE ZENA ace lt 7ESL QMS Certificat e mavAT A 5a BE Changes in critical processes such development and vigilance system PBPELIVAVYATLICNS SEB Change or relocation of authorized representative fHERKBAORS EMA Change of the user and or use Additional amended indications Change s influencing the clinical performance date BERLE AAO FB iB Mae FA BHMLEARORE a AR OTE REI Be SA SALIGES Change in safety related functions performance data materials parameters listed on the certificate identification instructions for use RO aL Fe 7 AREAS ace AI REBT SHEE REIL ES ST F MB NDA F l HF SER Name of product model NETIA Changes in the components in a system or set VAT LPCYLORKAOEF po Changes related to Product Certificat Minimum documentation that must be submitted FEW 727 REO SE HAI KI TIHEM SSA SH CHEEK CEB CEWET Application Procedure process description AE 4870ta Application plus Appendices B or C F252 RU Appendices B tI amp C Excerpt from the register of companies contract with new EC representative transition plan for Product labeling SHS BMA OORP SLU ERB A CORE Ql mA LERAORTHE Application plus Appendix A Verification report clinical data FA U Appendix A RIRES GATS Application Verification report Application plus Appendix A Verification report FA U Appendix A Ril S Application Plus A
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